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New hope for tough prostate cancer: targeted radiation drug enters phase 2 trial

NCT ID NCT06402331

Disease control Sponsor: Fusion Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new radioactive drug, FPI-2265, in 110 men with a hard-to-treat type of prostate cancer that has spread and stopped responding to standard hormone therapy. Participants must have already received a similar radioactive treatment. The goal is to find the safest dose and see if it can shrink tumors or lower PSA levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

110 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Diagnosis of adenocarcinoma of prostate proven by histopathology. * Must have had prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum/plasma testosterone * Progressive mCRPC at time of study entry. * Must have been previously treated with lutetium-PSMA therapy (lutetium-177 vipivotide tetraxetan or other lutetium-177-PSMA RLT). Treatment must have been completed \>6 weeks prior to the first dose of study drug. * Participants with known BRCA mutations should have received FDA-approved therapies such as PARP inhibitors, per Investigator discretion. * Positive PSMA PET/CT scan * Adequate organ function * For participants who have partners of childbearing potential: Partner and/or participant must not be planning to conceive and must use a method of birth control with adequate barrier protection deemed acceptable by the Principal Investigator during the study treatment and for six months after last study drug administration. Key Exclusion Criteria: * Participants who received more than two prior lines of cytotoxic chemotherapy for CRPC. * Participants who progress prior to administration of the 3rd cycle of prior treatment with 177Lu-PSMA therapy * All prior treatment-related adverse events must have resolved to Grade ≤1 (CTCAE v5.0). Alopecia and stable persistent Grade 2 peripheral neuropathy may be allowed at the discretion of the Investigator. * Participants with known, unresolved, urinary tract obstruction are excluded. * Administration of any systemic cytotoxic or investigational therapy ≤30 days of the first dose of study treatment or five half-lives, whichever is shorter. Completion of large-field external beam radiotherapy ≤four weeks of the first dose of study treatment. * Participants with a history of central nervous system (CNS) metastases are excluded except those who have received therapy * Participants with any liver metastases will be excluded * Participants with skeletal metastases presented as a superscan on a ⁹⁹ᵐTc bone scan. * Previous or concurrent cancer that is distinct from the cancer under investigation in primary site or histology, except treated cutaneous basal cell carcinoma or squamous cell carcinoma and superficial bladder tumors. Any cancer curatively treated \>two years prior to the first dose of treatment is permitted. * Concurrent serious (as determined by the investigator) medical conditions * Major surgery ≤30 days prior to the first dose of study treatment.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

Contacts and locations

Locations

  • BAMF Health

    Grand Rapids, Michigan, 49503, United States

  • Biogenix Molecular, LLC

    Miami, Florida, 33165, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Hoag Health Center Irvine

    Irvine, California, 92618, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Memorial Sloan Kettering Cancer Center - NYC

    New York, New York, 10065, United States

  • New Mexico Oncology Hematology Consultants Ltd.

    Albuquerque, New Mexico, 87109, United States

  • Oregon Health and Science University (OHSU, Knight Cancer Center)

    Portland, Oregon, 97239-3098, United States

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63104, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • U.T. MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCSF School of Medicine

    San Francisco, California, 94143, United States

  • United Theranostics

    Glen Burnie, Maryland, 21061, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073, United States

  • VA North Texas Health Care System, Nuclear Medicine Service

    Dallas, Texas, 75216, United States

  • XCancer

    Omaha, Nebraska, 68130, United States

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